Off-label prescribing, or prescription of drugs for uses not listed on their labels, may provide benefits to patients in exceptional circumstances, though the lack of regulation of off-label prescription may be harmful to patients, according to an editorial in Health Affairs.
Approximately 70 percent of off-label prescription is not evidence-based, according to the article. The author suggests off-label prescription is in part driven by pharmaceutical companies' desire to increase sales and profits. In addition, he notes manufacturers may have incentives to engage in promotion when benefits outweigh potential penalties, though the practice is illegal in this context.
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To improve patient safety, he suggests the Food and Drug Administration begin to regulate off-label prescription practices through supporting a physician reimbursement schema that incentivizes collection of off-label prescription information for each patient. The data could provide important insights into off-label prescription practices, especially considering more than two-thirds of it is not supported by evidence, according to the article.
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